Land: Australië
Taal: Engels
Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)
FRUNEVETMAB
ZOETIS AUSTRALIA PTY LTD
PARENTERAL LIQUID/SOLUTION/SUSPENSION
FRUNEVETMAB Active 7.0 mg
1 x 1 mL vial; 2 x 1 mL vials; 6 x 1 mL vials
VM - Veterinary Medicine
IMMUNOTHERAPY
Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [FOR THE CONTROL OF PAIN AND INFLAMMATION ASSOCIATED WITH OSTEOARTHRITIS, PAIN/INFLAMMATION ASSOCIATED WITH NONINF]
Registered
2023-07-01
SOLENSIA Solution for Injection for Cats 89387/124578 Product Name: APVMA Approval No: Label Name: SOLENSIA Solution for Injection for Cats Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY READ SAFETY DIRECTIONS Constituent Statements: Each 1 mL vial contains 7 mg frunevetmab. Claims: For use by or under direction of a registered veterinarian. For the alleviation of pain associated with osteoarthritis in cats. Net Contents: 1 x 1 mL vial 2 x 1 mL vials 6 x 1 mL vials Directions for Use: Restraints: Contraindications: This product must not be used in cats intended for breeding. This product must not be used in pregnant or lactating cats as Nerve Growth Factor (NGF) plays a key role in foetal nervous system development. This product must not be used in cats under 12 months of age, weighing less than 2.5 kg. This product must not be used in cats with hypersensitivity to frunevetmab. Precautions: There are no safety data on the concurrent use of non-steroidal anti-inflammatory drugs (NSAIDs) and frunevetmab in the cat. The safety and efficacy of this product has not been investigated in cats with kidney disease IRIS stages 3 and 4. Use of the product in such cases should be based on a benefit-risk assessment performed by the responsible veterinarian. RLP APPROVED This veterinary medicinal product may induce transient or persistent anti-drug antibodies. The induction of such antibodies may reduce the efficacy of the product although this was not observed during the 84 days of the pivotal clinical trial. No information is available for longer duration treatment. Side Effects: Focal skin reactions (e.g. pruritis, dermatitis and alopecia) occurred commonly in studies (i.e. between 1 and 10 animals in every 100 animals treated). Dosage and Administration: Avoid excessive shaking or foaming of the solution. Use the contents immediately after broaching the vial. Discard any unused portion. Remove the vial(s) from the carton at the time of monthly treatment, withdraw all liq Lees het volledige document